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Senior Automation Specialist

2 months ago

College Station, Texas, United States CPMNA Full time
Job Overview

Salary: Competitive

The Senior Automation Specialist is responsible for providing expert technical support and oversight for the execution of critical capital projects essential to the success of CPMNA. This role involves active participation in the development, installation, operation, maintenance, and repair of all automation systems to achieve organizational objectives. Collaboration with operators, calibration technicians, and engineers is crucial to maintain complex systems effectively.

Key Responsibilities:

  • Act as the Subject Matter Expert during validation processes to ensure compliance with relevant regulations (e.g., 21 CFR Part 11 and cGMP).
  • Collaborate with IT to ensure compliant integration with Corporate IT infrastructure.
  • Assist in the preparation and participation in system specification development and design.
  • Provide daily support for Building Management Systems and Process Control Systems.
  • Engage in coding, programming, and configuration for both continuous and batch control systems.
  • Oversee DeltaV Batch recipe configuration, including phases, EMs, and CMs.
  • Develop procedures for transferring technologies, recipes, and parameters from process development to commercial manufacturing.
  • Manage DeltaV Virtualization responsibilities.
  • Ensure proper configuration and maintenance of the OSI Soft PI Historian.
  • Maintain Functional Specifications, Database Design Specifications, and Hardware Design Specifications for automation systems.
  • Create and uphold Automation Standard Operating Procedures and training for Automation Systems.
  • Execute Engineering Test Plans for Automation.
  • Support and maintain automation reporting systems, such as Infobatch.
  • Conduct Software Test Specifications.
  • Ensure backups of automation code are maintained.
  • Provide engineering and technical reviews for new equipment purchases, including Request for Quote Bid Packages, design reviews, FAT, and SAT.
  • Perform all duties in a compliant and ethical manner, adhering to applicable laws, regulations, and industry standards.
  • Ensure compliance with cGMP practices in bulk drug and vaccine manufacturing environments.
  • Carry out additional duties as assigned.

Required Skills & Qualifications:

  • Proficient in Manufacturing Enterprise Systems, including Weight and Dispense and EBR.
  • Experience with Process Control Systems, SCADA design, implementation, and operations.
  • Ability to develop new code for continuous and batch control.
  • Knowledge of BMS, SCADA, and DCS design, commissioning, and validation in GMP facilities.
  • Familiarity with GAMP and other System Development Life Cycle (SDLC) methodologies, including CAPA.
  • Understanding of 21 CFR Part 11 compliance.
  • Knowledge of automation protocols such as HART, Foundation Fieldbus, Traditional I/O, Profibus, Ethernet I/P, OPC, and Modbus TCP/IP.
  • Experience with DCS, SCADA, and BMS systems like DeltaV, Factory Talk View, and APOGEE.
  • A reliable, self-motivated individual with a positive attitude, capable of working collaboratively with diverse teams.
  • Strong time management skills and the ability to prioritize tasks effectively.
  • Excellent written, verbal, and interpersonal communication skills, with a keen attention to detail.
  • Ability to work independently with minimal supervision in a dynamic work environment.
  • Proficient in MS Office applications (Word, Excel, Outlook, PowerPoint).
  • A desire to work in a fast-paced, state-of-the-art research and customized manufacturing facility.

Working Conditions & Physical Requirements:

The physical demands of this position include:

  • Prolonged periods of sitting, standing, bending, stooping, climbing, and stretching.
  • Sufficient hand-eye coordination and manual dexterity to operate office equipment.
  • Ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
  • Exposure to noisy environments.
  • Availability to support manufacturing activities around the clock.
  • Regular attendance is required.

Minimum Qualifications:

  • Bachelor's Degree in Chemical, Electrical, Mechanical Engineering, or a closely related field, with a minimum of five (5) years of relevant automation engineering experience, preferably in the biotechnology or pharmaceutical industry.

Preferred Qualifications:

Experience with critical utility and non-GMP utility systems is advantageous.